K-number	K180129
Device name	Imbio Segmentation Editing Tool software
Applicant	Imbio, LLC
Product code	LLZ
Device class	Class II
Decision date	Mar 16, 2018
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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Imbio Segmentation Editing Tool software

Everything you need for a 510(k) submission. Nothing you don't.